The Recall Desk

FDA (Devices) recall action 57878

App Pharmaceuticals Llc recalled 2 products on 2012-06-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-06-27
Critical
0
Units
133,150

Why these products were recalled

CGMP Deviations: Incomplete documentation associated with test results.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood s
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, ND
    Category
    Distribution
    1 state